BR112021008489A2 - implantable artificial bronchus, and, methods for promoting lung deflation and for delivering implantable artificial bronchus into an air passage. - Google Patents

Abstract

IMPLANTABLE ARTIFICIAL BRONCHIS, AND, METHODS TO PROMOTE PULMONARY DEINFLATION AND TO DELIVER BRONCHIS ARTIFICIAL IMPLANTABLE IN AN AIR PASSAGE . an artificial bronchus implantable device that includes a body having an upper proximal opening and a distal inferior opening. The distal inferior opening being in fluid communication with the upper proximal opening, and the body tapering at least partially along a length towards to the distal inferior opening. The body having a plurality of side openings configured to allow air inlet and outlet of the implantable artificial bronchus through the body. a length of the body is 4 times the size of a larger diameter of the body and the proximal upper opening diameter is greater than a diameter of the distal inferior opening.

Description

1 / 30 IMPLANTABLE ARTIFICIAL BRONCHIUM, E, METHODS FOR

PROMOTE PULMONARY DEINFLATION AND TO DELIVER ARTIFICIAL BRONCHUM IMPLANTABLE IN A PASSAGE OF

AR Cross-reference to related patent applications

[001] This patent application claims the benefit thereof to Provisional US Patent Application No. 62/769 104, filed November 19, 2018 and entitled "Implantable Artificial Bronchus", and to Provisional US Patent Application No. 62/805 568, filed on February 14, 2019 and entitled “Implantable Artificial Bronchus”, the contents of which are incorporated herein in their entirety by reference. field of invention

[002] The present invention relates, in general, to an implantable artificial bronchus and to implantation methods thereof for the treatment of pulmonary emphysema and chronic obstructive pulmonary disease (COPD). Fundamentals of Invention

[003] Chronic obstructive pulmonary disease (COPD) can result in long-term respiratory problems, airflow limitation, shortness of breath, coughing, and sputum production. Pulmonary emphysema is a form of COPD that is present in most people with COPD.

[004] Pulmonary emphysema is characterized by the permanent enlargement of the units responsible for gas exchange in the lungs, acini, due to the disruption of lung tissue and destruction of the alveolar walls. This gradual and irreversible degradation of lung tissue leads to the loss of the lung's elastic recoil capacity, expressed by the inability to expel inspired air. Furthermore, the degradation of lung tissue contributes to the restriction of air flow and, thus, to the malabsorption and release of respiratory gases.

2 / 30

[005] Current treatments for pulmonary emphysema are limited and only provide symptomatic improvement. For example, most current medications only address the inflammatory component. Furthermore, administration of supplemental oxygen to hypoxic patients and pulmonary rehabilitation are the only clinical treatments that have been shown to improve mortality in severe cases of COPD. Surgical approaches, such as surgical reduction of lung volume, are indicated only for a small proportion of patients and the procedure is invasive, as it requires the removal of diseased, emphysematous tissue from the lung. Other methods, such as bronchoscopy techniques and stents, are currently being developed for the treatment of severe COPD and have made progress over the past decade. However, these methods do not allow for bidirectional airflow, do not delve sufficiently into the distal levels of the respiratory bronchioles, or provide long-term improvements to patients, for example, by early closure of the implanted stent or by accelerating patient damage.

[006] Consequently, there is a need for a more effective treatment for pulmonary emphysema and COPD that is minimally invasive, includes bidirectional airflow, is able to reach the deeper generations of respiratory bronchioles and that does not result in further harm to the patient long-term or trigger healing mechanisms within the lung. Brief summary of the invention

[007] Embodiments of the present invention are directed to an implantable artificial bronchus, which includes a body with an upper proximal opening and a lower distal opening in fluid communication with the upper proximal opening, the body tapering at least partially along a length of the body towards the distal lower opening, and which has a plurality of side openings configured to allow the

3 / 30 implantable artificial bronchus air inlet and outlet through the body. A body length is 4 times the size of a larger body diameter and a proximal upper opening diameter is greater than a distal lower opening diameter.

[008] In some embodiments, the body may include a proximal portion, a first middle portion, a second middle portion, and a distal portion, the proximal portion tapering toward a central geometric axis of the body. The first middle portion and the second middle portion can be disposed between the proximal portion and the distal portion. The first middle portion may be close to the proximal portion and the second middle portion being close to the distal portion. The first mid portion may have a first taper and the second mid portion may have a second taper, the second taper may be greater than the first taper.

[009] In some embodiments, a first middle portion diameter may be greater than a proximal portion diameter, a second middle portion diameter, and a distal portion diameter. The diameter of the distal portion may be smaller than the diameter of the proximal portion, the diameter of the first middle portion and the diameter of the second middle portion. The diameter of the first middle portion can be equal to or less than the largest diameter of the body. The diameter of the second mid-portion may steadily decrease along the length of the body from the first mid-portion to the distal portion. The diameter of the distal portion may be substantially equal near the second middle portion and near the lower distal opening.

[0010] In some embodiments, the proximal portion may extend from the upper proximal opening to the first middle portion.

[0011] In some embodiments, a maximum body diameter may be greater than the diameter of the upper proximal opening.

[0012] In some modalities, the body can be a web,

4 / 30 composed of the single fiber forming a truss structure, the single fiber can have the ends woven together, close to a middle portion of the body. The single fiber can be coated with at least one of silicone or polymer.

[0013] In some embodiments, the diameter of the upper proximal opening is twice the diameter of the lower distal opening.

[0014] In some embodiments, in an deployed state, the body may be configured to curve in a first radial direction along a first length of the body and a second radial direction opposite the first radial direction along a second length of the body. body.

[0015] In some embodiments, the plurality of side openings may include an angle ranging from approximately 130° near the upper proximal opening to 20° near the lower distal opening.

[0016] In some embodiments, the implantable artificial bronchus may include at least one retrieval loop coupled to the body at the upper proximal opening. At least one retrieval loop may extend from the proximal upper opening in a direction substantially parallel to a central axis of the body.

[0017] In some embodiments, the implantable artificial bronchus includes at least one radiopaque marker disposed in the body.

[0018] In some embodiments, the body may have a maximum diameter between approximately 6 mm and 12 mm. The body can be composed of PEEK. The body can be composed of NiTiNOL. In addition, the body can include the single fiber arranged in an alternating cross-weaving pattern.

[0019] In some embodiments, the implantable artificial bronchus may not include a valve or a nozzle attached to the body.

[0020] Another embodiment of the present invention can provide an implantable artificial bronchus that includes a body with an opening

5 / 30 upper proximal and a lower distal opening in fluid communication with the upper proximal opening, the upper proximal opening tapering towards a central axis of the body. The body may constantly taper from a portion near the upper proximal opening toward a portion near the lower distal opening, and may have a plurality of side openings configured to allow air in and out of the implantable artificial bronchus through the body. The body may include a proximal portion tapering toward a central geometric axis of the body, a first medial portion having a first median taper, a second median portion having a second median taper greater than the first median taper, and a distal portion having a constant distal diameter. The first middle portion and the second middle portion can be disposed between the proximal portion and the distal portion. A diameter of the upper proximal opening may be at least twice a diameter of the lower distal opening, and the diameter of the upper proximal opening may be less than a maximum diameter of the body, the maximum diameter of the body being close to the upper proximal opening. In an deployed state, the body may be configured to curve in a first radial direction along a first body length and a second radial direction opposite the first radial direction along a second body length.

[0021] Another embodiment of the present invention can provide a method for promoting pulmonary deflation, wherein the method includes inserting a catheter distally into a respiratory passage of a patient's lung, the catheter containing the implantable artificial bronchus compressed within the catheter , and withdraw the catheter proximally to the implantable artificial bronchus, unsheathing the implantable artificial bronchus, causing the implantable artificial bronchus to naturally expand and remain in the respiratory passage, the implantable artificial bronchus configured to promote the passage widening

6/30 respiratory.

[0022] In some modalities, the catheter may be a guiding catheter and the implantable artificial bronchus may extend in one passage to the bronchioles.

[0023] Another embodiment of the present invention may provide a method of delivering the implantable artificial bronchus to an air passageway, wherein the method includes inserting the implantable artificial bronchus into a delivery device. The delivery device may include a handle having a proximal end, a distal end, an outer surface, and an actuator movable on the outer surface. The delivery device may further include a delivery portion including an outer sheath and a delivery wire, the outer sheath coupled to the handle driver and extending outwardly from the distal end of the handle, the outer sheath having a distal end and hair. minus a cleft, in which the implantable artificial bronchus is inserted into the delivery device through the distal end. The delivery wire may be coupled to a proximal end of the cuff and extend outwardly from the distal end of the cuff and into the outer sheath such that the delivery wire is disposed within the outer sheath, the delivery wire including a braking element, wherein the braking element is disposed close to the implantable artificial bronchus after insertion of the implantable artificial bronchus into the delivery device. The method further includes inserting the delivery portion of the delivery device into a bronchoscope such that the outer sheath is disposed within a working channel of the bronchoscope, advancing the delivery portion through the bronchial passageway through the bronchoscope, retracting the sheath external, through the actuator, expose the delivery wire and the implantable artificial bronchus, causing the implantable artificial bronchus to naturally expand and remain in the bronchial passage, and remove the delivery device from the passage

7/30 bronchial through the working channel of the bronchoscope.

[0024] In some embodiments, insertion of the implantable artificial bronchus into the delivery device includes threading a suture through at least one proximal loop of the implantable artificial bronchus, pulling the suture to cause the implantable artificial bronchus to collapse, inserting the suturing the implantable artificial bronchus through the distal end of the outer sheath and removing the suture from the implantable artificial bronchus and delivery device through at least one slit such that the implantable artificial bronchus remains in the delivery device. Brief description of the drawings

[0025] The above summary as well as the detailed description below of implantable artificial bronchus modalities will be better understood when read in conjunction with the attached drawings of exemplary modalities. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown.

[0026] Figure 1 is a perspective view of an exemplary implantable artificial bronchus in accordance with an embodiment of the present invention; Figure 2 is a side view of the implantable artificial bronchus shown in Figure 1; Figure 3 is a cross-sectional view of a proximal end of the implantable artificial bronchus shown in Figure 1; Figure 4 is a cross-sectional view of a distal end of the implantable artificial bronchus shown in Figure 1; Figure 5 is a close-up view of a distal end of the implantable artificial bronchus shown in Figure 1; Figure 6 is a side view of the implantable artificial bronchus of Figure 1 shown with a retrieval loop; Figure 7 is a perspective view of the artificial bronchus.

8/30 implantable shown in Figure 6; Figure 8 is an illustration of a lung showing compressed branches; Figure 9 is an illustration of exemplary use of the exemplary implantable artificial bronchus in accordance with an embodiment of the present invention; Figure 10 is an illustration of exemplary use of the exemplary implantable artificial bronchus in accordance with an embodiment of the present invention; Figures 11A-B are illustrations of an exemplary measuring catheter in accordance with an embodiment of the present invention; and Figures 12A-D are illustrations of an exemplary delivery device in accordance with an embodiment of the present invention. Detailed description of exemplary embodiments of the invention

[0027] Exemplary embodiments of the present invention provide an implantable artificial bronchus and methods of implanting the same. In use, the implantable artificial bronchus 100 can facilitate the opening of the airways in individuals with COPD and pulmonary emphysema. Specifically, the implantable artificial bronchus 100 can permit the escape of air trapped within the respiratory passages, such as the bronchi and bronchioles, by opening and holding the respiratory passages open. Implanting the implantable artificial bronchus 100 in the respiratory passage can prevent restriction of the walls of the bronchi and bronchioles, thereby allowing airflow through the passages. As shown in Figures 1 and 2, the implantable artificial bronchus 100 may include the body 102, the upper proximal opening 104, the lower distal opening 106, the wire or fiber 108, and the lateral openings 110. The body 102 may be disposed between the upper proximal opening 104 and the lower distal opening 106, and may be composed of a fiber 108. The implantable artificial bronchus 100 may be at least partially

9 / 30 tapered to allow insertion into the bronchi and penetration of the implantable artificial bronchus 100 into distal bronchioles that become increasingly narrow. For example, the implantable artificial bronchus 100 can be implanted within the respiratory passage such that the upper proximal opening 104 is disposed within the bronchi, and the lower distal opening 106 is able to get as close as possible to the respiratory bronchioles at levels 9 to 15 (terminal bronchioles).

[0028] As shown in Figures 1 and 2, the implantable artificial bronchus 100 can be comprised of the body 102. In one embodiment, the body 102 is unobstructed and does not include a valve coupled to the body 102. The body 102 of the implantable artificial bronchus 100 it may be generally cylindrical towards the upper proximal opening 104, tapered over the majority of the body 102, and generally cylindrical towards the lower distal opening 106. The body 102 may have a maximum diameter D3 and may be tapered along the length L of the body 102, near the upper proximal opening 104, and between the upper proximal opening 104 and the lower distal opening 106. For example, the body 102 may include the proximal portion 120, the first middle portion 122, the second middle portion 124, and the portion distal 126. First middle portion 122 and second middle portion 124 may be disposed between proximal portion 120 and distal portion 126, with first middle portion 122 being proximal to proximal portion 120 and adjacent to each other. the middle portion being proximate to the distal portion 126. The proximal portion 120 may taper toward a central axis A and may have an inclination 128, which may be between approximately 40-50 degrees relative to the central axis A and may slope towards the upper proximal opening 104. The first middle portion 122 may have a larger diameter than the proximal portion 120 and may be generally cylindrical in shape. For example, the first middle portion 122 may have a generally uniform diameter or may have a slight taper toward a central geometric axis A.

The first middle portion 122 may have an inclination 130 which may be between approximately 2-4 degrees with respect to the central geometric axis A and may slope towards the lower distal opening 106. The first middle portion 122 with a diameter larger than the proximal portion 120 allows the first middle portion 122 to engage the walls of the bronchi, preventing them from collapsing, and securing the implantable artificial bronchus 100. For example, the first middle portion 122 may allow the implantable artificial bronchus 100 to become proximally anchored at levels 3 or 4 of the bronchi.

In one embodiment, the diameter of the first middle portion 122 can be substantially equal to the maximum diameter D3. In another embodiment, the maximum diameter D3 can be disposed between the proximal portion 120 and the first medial portion 122. The proximal portion 120 and the first medial portion 122 can be disposed within the bronchi.

The second middle portion 124 may be conical in shape.

The second middle portion 124 may taper towards a central geometric axis A and may have a gradually decreasing diameter.

The second middle portion 124 may have an inclination 132, which may be between approximately 10-12 degrees with respect to the central geometric axis A and may slope towards the lower distal opening 106. The diameter of the second middle portion 124 may be less to the diameter of the first middle portion 122 and may taper at a faster rate as compared to the first middle portion 122. A section of the second middle portion 124, close to the first middle portion 122, can be disposed in the bronchi.

The second middle portion 124 may extend to the bronchioles and taper to the distal portion 126. The distal portion 126 may be cylindrical in shape and have a smaller diameter than the second medial portion 124, the first medial portion 122 and the proximal portion 120. Distal portion 126 can be disposed within the bronchioles.

In one embodiment, the distal portion 126 does not include any taper such that the diameter of the distal portion 126, near the second middle portion 124, is equal to the diameter.

11 / 30 near the distal lower opening 106. For example, the distal portion 126 may have an inside diameter of approximately 2 mm, which may be substantially equal to the diameter D2 of the distal lower opening 106. In one embodiment, the distal portion 126 tapers toward a central axis A and may be inclined 134, which may be between approximately 1-3 degrees relative to the central axis A and may be inclined toward the lower distal opening 106. In yet another embodiment, a distal portion 126 may widen away from the central geometric axis A. For example, distal portion 126 may widen to prevent too deep insertion of the implantable artificial bronchus 100 into the bronchioles. The slopes 128,130, 132 and 134 can be between approximately 0 degrees and 15 degrees. Slopes 128,130, 132 and 134 may vary based on the length L of the body 102. For example, the inclination 132 of the second middle portion 124 may be approximately 4.3 degrees when the length L is approximately 50 mm and may be approximately 2.7 degrees when length L is approximately 80 mm. In some embodiments, it is advantageous to have a greater degree of taper for the slopes 128, 130, 132 and 134 positioned in the placement placement of the implantable artificial bronchus.

[0029] In one embodiment, the shape and length of the body 102 allow the implantable artificial bronchus 100 to be inserted into a respiratory passage to keep the respiratory passages open in respiratory bronchioles beyond level 15, close to the alveoli (levels >15) , resulting in the escape of trapped air in lower generations. According to an embodiment of the present invention, the length L of the body 102 can be 4 times greater than the maximum diameter D3 of the body 102. For example, the maximum diameter D3 of the body 102 can be between 9.5 millimeters and 10, 5mm, and the maximum body length L 102 can be 50mm or 80mm. In some embodiments, the length L of the

12 / 30 body 102 can be 2.5; 3; 3.5; 4.5; 5.5; 6; 6.5; 7; 7.5; 8; 8.5; 9; 9.5; or 10 times larger than the maximum diameter D3 of the body 102. The maximum diameter D3 of the body 102 of 9 millimeters may allow the implantable artificial bronchus 100 to be implanted into 6-8 millimeters of bronchi. However, the maximum diameter D3 can be any desired size, such as approximately 6mm, approximately 7mm, approximately 8mm, approximately 10mm, approximately 11mm or approximately 12mm, and the maximum length L of the body 102 may be greater than 80mm, less than 50mm or between 50 and 80mm. In one embodiment, the maximum diameter D3 of the implantable artificial bronchus 100 is made to be approximately 10.5 mm, which is reduced to approximately 8 mm or less when implanted into the respiratory passage. In use, the maximum diameter D3 can range between 25-50% based on the respiratory cycle and the dilation and constriction of the respiratory passages. The maximum diameter D3 may also vary due to the flexibility of the implantable artificial bronchus 100. For example, the maximum diameter D3 may increase or decrease based on variations in the diameter of the bronchus, such as during a respiratory cycle. The maximum length L of body 102 can be varied in size so that its dimensions fit within shorter or longer air passages. For example, the maximum body length L 102 can be longer to penetrate deeper, thinner respiratory bronchioles.

[0030] In one embodiment of the present invention, a kit may be provided that includes multiple implantable artificial bronchi 100 having various maximum length L of the body 102. For example, a kit may include an implantable artificial bronchus 100 wherein the maximum length L of the body 102 is 50mm, another implantable artificial bronchus 100 wherein the maximum body length L 102 is 80mm and a third implantable artificial bronchus 100 wherein the maximum body length L 102 is

13 / 30 greater than 80mm. A surgeon may choose an implantable artificial bronchus 100 from the kit having the specific maximum body length L 102 based on a patient's anatomy. In addition, the maximum diameter D3 of the body 102 may be located in a portion close to the upper proximal opening 104 and may be sized so that it is pressed against the walls of the bronchi at the upper levels of the respiratory passages. The maximum diameter D3 being located close to the upper proximal opening 104 can prevent or reduce contact of the upper proximal opening 104 with the walls of the bronchi, which can aid in the adjustment, retrieval and removal of the implantable artificial bronchus 100 through an upper opening. proximal 104.

[0031] According to an embodiment of the present invention, the diameter of the body 102 may decrease from a portion of the body 102, close to the upper proximal opening 104, to the lower distal opening 106. For example, the body 102 may constantly taper from a portion proximate the upper proximal opening 104 towards the lower distal opening 106. The body 102 can constantly taper from the maximum diameter D3 of the body 102, which may be approximately 9.5 mm, to the diameter D2 of the lower distal opening 106, which can be approximately 2 mm. In other embodiments, body 102 tapers slightly at first from the end, more dramatically in the middle, and then slightly or not at all towards the distal end. For example, body 102 may taper constantly from maximum diameter D3 to an area of body 102, for example, located approximately 2 mm from the distal lower opening 106. Thereafter, body 102 may be flat, with no taper, in length. remaining approximately 2 mm. The taper ratio of body 102 can vary based on the maximum length L of body 102. For example, the taper ratio of body 102 can be greater if the maximum length L of body 102 is smaller.

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[0032] Referring to Figures 1 and 2, the upper proximal opening 104 may be in fluid communication with the lower distal opening 106 to allow bidirectional airflow into and through the implantable artificial bronchus 100. The upper proximal opening 104 may have the diameter D1 and the lower distal opening 106 can have the diameter D2. Under some embodiments, the diameter D1 of the upper proximal opening 104 may be greater than the diameter D2 of the lower distal opening 106. For example, the diameter D1 of the upper proximal opening 104 may be twice the diameter D2 of the distal lower opening 106. In another example, the diameter D1 of the upper proximal opening 104 may be approximately 7.5 mm and the diameter D2 of the lower distal opening 106 may be approximately 2 mm. However, the diameter D1 of the upper proximal opening 104 can be between approximately 5 mm and 14 mm, between approximately 6 mm and 13 mm, between approximately 7 mm and 12 mm, between approximately 8 mm and 11 mm, or between approximately 9 mm and 10 mm. In addition, the diameter D2 can be between approximately 0 mm and 6 mm, between approximately 1 mm and 5 mm, or between approximately 2 mm and 4 mm. In practice, the diameter D1 of the upper proximal opening 104 and the diameter D2 of the lower distal opening 106 can be sized to fit within and reach various levels of respiratory bronchi and bronchioles such as distal bronchioles. For example, in one embodiment, the diameter D2 of the lower distal opening 106 can be sized to be between approximately 2 mm and approximately 3 mm and fit within and reach level 15 respiratory bronchioles, which have a diameter of between approximately 2, 5mm and approximately 3mm. Also, in another modality, the D2 diameter of the lower distal opening may be less than approximately 2 mm, such as 1.5 mm, to fit in and reach deeper levels of respiratory bronchioles, such as 16/18 levels of bronchioles which are approximately 1.5 to approximately 1 mm in diameter.

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[0033] As shown in Figure 3, the maximum diameter D3 of the body 102 may be greater than the diameter D1 of the upper proximal opening 104. In addition, a portion of the body 102, close to the upper proximal opening 104, may taper toward a central geometric axis A of the body 102 to allow easy and efficient removal of the implantable artificial bronchus 100 within the respiratory passage. For example, a portion of body 102 near upper proximal opening 104 that tapers toward a central axis A of body 102 prevents any portion of body 102 near upper proximal opening 104 from piercing lung tissue within. of a bronchus during insertion and positioning of the implantable artificial bronchus 100.

[0034] The body 102 may be a truss structure composed of woven yarn or fiber. In one embodiment, the body 102 is composed of a single piece of yarn or fiber 108. The single piece of fiber 108 can be arranged in a cross-weaving pattern to form a plurality of side openings 110. The ends of the single piece of fiber 108 can be connected and coupled together near the center of the body 102 and the connection of the single piece of fiber 108 can be disposed within a radiopaque marker.

112. In some embodiments, the ends of the single piece of fiber 108 can be woven together near the center of the body 102. For example, the ends of the single piece of fiber 108 can be woven together and disposed along the first middle portion 122. or second middle portion 124. However, the ends of the single piece of fiber 108 may be coupled together at any location of the body 102 or in other ways. The ends of the single piece of fiber 108 may be woven side by side, and may be going in opposite directions when woven together.

[0035] Although Figures 1 and 2 show fiber 108 as a single piece, fiber 108 can be composed of two or more strands of fiber. For example, the body 108 can be composed of two, three, four or any

16 / 30 number of interwoven fibers. The use of a plurality of fibers can increase the strength of the body 102 and reduce the fatigue of the body 102. In one embodiment, each fiber of the plurality of fibers can have a different diameter. For example, a fiber with a thicker diameter can be used for the proximal portion 120 and the first middle portion 122, and a fiber with a thinner diameter can be used for the second middle portion 124 and the distal portion 126. In one embodiment of the present invention, the multiple fibers can be arranged in parallel to each other to make up body 102. In another embodiment, the multiple fibers can be braided together to make up body 102. As shown in Figures 1 and 2, fiber 108 of the body 102 can be arranged in an alternating cross-weaving pattern, creating a warp-like structure. However, fiber 108 of body 102 can be arranged in any other desired manner. For example, fiber 108 of body 102 can be arranged in a braided fashion to provide a more rigid structure and maintain the shape of body 102.

[0036] According to an embodiment of the present invention, fiber 108 can be composed of a thermoplastic polymer, such as a poly(ether ether ketone) (PEEK). In other embodiments, fiber 108 is composed of one or more of polymer, metal, metal alloy, or stainless steel. Fiber 108 of body 102 can be made of a metal alloy that has a shape memory effect, such as NiTiNOL. However, fiber 108 can be a fiber of any other type of material, such as a polymer, wire mesh, or any other type of material, and can include a coating, such as silicone. In a preferred embodiment, fiber 108 of body 102 is composed of a single PEEK fiber. In some embodiments, fiber 108 of body 102 is composed of PEEK and has a diameter of 0.30 mm. In one embodiment, fiber 108 of body 102 is made of a shape memory material such as PEEK. Fiber 108 can have a diameter between approximately 0.15 and

17 / 30 approximately 0.40 mm. In a preferred embodiment, fiber 108 has a thickness of approximately 0.25 mm. In one embodiment of the present invention, to create the structure of body 102, fiber 108 is woven over a tapered mandrel, which may be made of titanium, ceramic, tool steel, or stainless steel. The tapered mandrel includes a series of pins to hold fiber 108 in place. The tapered mandrel may have a small proximal diameter to form the diameter D1 and may include grooves for positioning the fiber 108. The implantable artificial bronchus 100 can be made by placing and weaving the fiber 108 over the tapered mandrel to form the body 102. In one embodiment, the woven fiber assembly 108 is placed in an oven to heat 108 to a first temperature of approximately 140° and allowed to cool to define the shape of the body 102 of the implantable artificial bronchus 100. The implantable artificial bronchus 100 can then be placed in a second shaping shape, such as another mandrel, and heated to a second temperature of approximately 170°C to define the final shape of body 102. The first temperature and second temperature may vary based on the materials used.

[0037] In one embodiment of the present invention, as shown in Figure 5, fiber 108 may include a conformable coating 118. In one embodiment, coating 118 may be a coating material composed of silicone or other polymers. Fiber 108 can be covered with sheath 118 prior to formation of the final shape of the implantable artificial bronchus 100. Sheath 118 can be configured to add protection to fiber 108, aid biocompatibility of fiber 108, and reduce fiber 108 friction against the lung tissue from the respiratory passages of the bronchi and bronchioles to facilitate the insertion of the implantable artificial bronchus 100 into the respiratory passage. The coating 118 can have a thickness between 0.05 mm and 0.1 mm.

[0038] Continuing with reference to Figures 1 and 2, the body 102

18/30 may include side openings 110. Side openings 110 may be created by interweaving fiber 108. Body 102 may be formed only of fiber 108 and may include only side openings 110 disposed along length L of body 102. In one embodiment of the present invention, the side openings 110 may be in direct contact with surrounding tissue.

For example, the body 102 and the implantable artificial bronchus 100 may not include any covers or sheaths around them, allowing the lateral openings 110 to directly contact the walls surrounding the bronchi and bronchioles.

In practice, the lateral openings 110 can be configured to allow the entry and exit of air from the implantable artificial bronchus 100 through the body 102. The lateral openings 110 of the implantable artificial bronchus 100 can allow access to other respiratory passages that branch out of the main respiratory passage where the implantable artificial bronchus 100 is implanted.

These other air passages can be created due to collateral ventilation.

As shown in Figures 1 and 2, side openings 110 may be disposed along the entire length L of body 102. Side openings 110 may be disposed of body 102 near upper proximal opening 104 and near lower distal opening 106. Although Figures 1 and 2 show diamond-shaped side openings 110, the side openings 110 can be any desired shape depending on the cross-weave pattern of the fiber 108. In one embodiment, the side opening 110 may include angles α and ß created. by the intertwining of fiber 108. The angles α and ß can be between approximately 130° and approximately 20°.

Angle α can be arranged close to upper proximal opening 104 and angle ß can be arranged close to lower distal opening 106. Angle α can be greater than angle ß.

In some modalities, angle α is less than 22º and angle ß is greater than 130º.

Angles α and ß may decrease along length L of body 102 from the upper proximal opening

19 / 30 104 to the lower distal opening 106. In one embodiment, the angle α is approximately 115° near the upper proximal opening 104, and the angle ß is approximately 22° near the lower distal opening 106. Decreasing angles α and ß from the upper proximal opening 104 to the lower distal opening 106 results in tapering of the body 102 along length L. In some embodiments, the body 102 may include between 15 and 35 side openings 110 disposed along the central axis A.

[0039] Referring to Figure 4, the lateral openings 110 may not be visible when the implantable artificial bronchus 100 is viewed from a distal end. For example, the lateral openings 110 may be arranged along the body 102 in such a way that, when the implantable artificial bronchus 100 is viewed from a distal end, the lateral openings 110 may not be visible to prevent or limit the lateral openings 110. engage with surrounding tissue during insertion and implantation of the implantable artificial bronchus 100.

[0040] Referring to the Figures. 1-4, the implantable artificial bronchus 100 may include one or more radiopaque markers 112. One or more radiopaque markers 112 may be disposed at various locations in the implantable artificial bronchus 100. For example, as shown in Figures 1-3, the radiopaque marker 112 may be disposed on body 102, near upper proximal opening 104. However, radiopaque marker 112 may be disposed anywhere along body 102, such as proximal portion 120, first middle portion 122, second portion middle 124 or the distal portion 126. The implantable artificial bronchus 100 may include any number of radiopaque markers 112 disposed throughout the body 100. For example, the implantable artificial bronchus 100 may include one, two, three, four, five, six, or any desired number of radiopaque markers

112. Radiopaque marker 112 can be used with known imaging techniques and can be used to determine bronchial placement

20 / 30 implantable artificial bronchus 100, and may also aid in the recovery or removal of the implantable artificial bronchus 100. In addition, the radiopaque marker 112 can be used to determine the exact location of specific portions of the implantable artificial bronchus 100 and the body 102. By For example, the radiopaque marker 112, disposed in the body 102 and proximal to the upper proximal opening 104, can indicate to a user the location of the proximal end of the implantable artificial bronchus 100 to determine the correct alignment and location of the implantable artificial bronchus 100. As an embodiment of the present invention, radiopaque marker 112 is disposed around fiber 108. As shown in Figure 3, fiber 108 can be inserted through radiopaque marker 112. However, radiopaque marker 112 can be disposed over fiber 108 or under fiber 108.

[0041] Referring to the Figures. 6 and 7, the implantable artificial bronchus 100 may include one or more retrieval loops 114. The retrieval loop 114 can aid in the retrieval and removal of the implantable artificial bronchus 100 from the respiratory passages. In one embodiment of the present invention, retrieval loop 114 is integrated with body 102. For example, retrieval loop 114 can be configured to integrate with the cross-weave pattern of fiber 108. Recovery loop 114 can be integrated. in the body 102 near the upper proximal opening 104. In another embodiment of the present invention, the retrieval loop 114 is a separate structure coupled to the body 102 as a secondary process. The retrieval loop 114 may be attached to the body 102 near the upper proximal opening 104 or any other location along the body 102. Although Figures 6 and 7 show the implantable artificial bronchus 100 with a retrieval loop 114, the artificial bronchus The implantable 100 can have any number of rescue loops 114. For example, the implantable artificial bronchus 100 can have two, three, four, or any desired number of recovery loops 114. The recovery loop 114 can be made of one

21 / 30 different material from fiber 108 of body 102 for increased strength during recovery and removal of implantable artificial bronchus 100. For example, recovery loop 114 can be made of materials such as stainless steel MP35N, 35N LT, 316L, titanium, polymers, suture materials, polypropylene, nylon or any other desired material. In addition, retrieval loop 114 may vary in diameter compared to fiber 108. In one embodiment, retrieval loop 114 may have a diameter of approximately 0.381 mm. However, retrieval loop 114 can have a diameter of any desired size. In one embodiment of the present invention, retrieval handle 114 includes handle 116. Handle 116 may be configured to allow a user to easily retrieve or remove implantable artificial bronchus 100 via retrieval handle 114. Handle 116 may be made of the same material as retrieval handle 114, or it may be made of different materials to increase the overall strength of retrieval handle 114.

[0042] In some embodiments of the present invention, the retrieval loop 114 includes one or more radiopaque markers 112. The presence of one or more radiopaque markers 112 with the retrieval loop 114 can aid in determining the location of the retrieval loop 14 and /or the implantable artificial bronchus 100, in addition to aiding in the retrieval of the implantable artificial 100. In one embodiment of the present invention, the retrieval loop 114 may be configured to be intertwined with the body 102 and compressed together with the body 102. retrieval 114 being compressed allows the entire implantable artificial bronchus 100 to be compressed to facilitate insertion and implantation.

[0043] In use, the implantable artificial bronchus 100 can be used to promote lung deflation. As shown in Figure 8, the lung 200 of an individual may include respiratory passages 202 with walls 204. The respiratory passages 202 may be bronchi or

22 / 30 bronchioles, and walls 204 can be bronchial walls or bronchiole walls depending on the depth within the respiratory passage.

202. In individuals with COPD and pulmonary emphysema, there may be restriction of the walls 204 of the respiratory passage 202, limiting airflow, as indicated by the arrows in Figure 8. The implantable artificial bronchus 100, as shown in Figure 9, can be used to keep the walls 204 of the respiratory passage 202 unrestricted, allowing the flow of air, as represented by the arrows in Figure 9. Specifically, the implantable artificial bronchus 100 can allow the escape of air trapped within the respiratory passage 202 by opening and keep the bronchi and bronchioles open.

[0044] Referring to the Figures. 9-10, in one embodiment, the implantable artificial bronchus 100 is positioned in the respiratory passage by a surgeon inserting a catheter distally into a lung's respiratory passage. The catheter may contain the implantable artificial bronchus 100 which can be compressed into the catheter. For example, the implantable artificial bronchus 100 can be compressed radially toward the central geometric axis A, reducing the diameter of the implantable artificial bronchus 100 to fit the implantable artificial bronchus 100 within the catheter during insertion and implantation. The catheter can be withdrawn proximally to the implantable artificial bronchus 100, unsheathing the implantable artificial bronchus 100 and causing it to naturally expand and remain in the respiratory passage. In another embodiment of the present invention, the implantable artificial bronchus 100 is coupled to a bronchoscope for positioning the implantable artificial bronchus 100 within respiratory passages. In a preferred embodiment, the implantable artificial bronchus 100 is composed of a material, such as PEEK, that allows the implantable artificial bronchus 100 to expand into its original shape. As shown in Figure 9, the implantable artificial bronchus 100 within the respiratory passages can be configured to promote widening of the

23 / 30 bronchial passage and, in turn, cause pulmonary deflation.

[0045] In one embodiment of the present invention, insertion of the implantable artificial bronchus 100 into the respiratory passage 202 is performed with a channel bronchoscope. For example, a 2.8 mm channel bronchoscope can be used to aid in the insertion and implantation of the implantable artificial bronchus 100 into the respiratory passage 202. In one embodiment, the bronchoscope aids in the delivery of the implantable artificial bronchus 100 to the 15 level of the bronchioles respiratory symptoms. As the implantable artificial bronchus 100 expands from its compressed state, the implantable artificial bronchus 100 may be able to reach deeper respiratory bronchioles, such as levels 17, 18, or 19. For example, the implantable artificial bronchus 100 may be positioned within of the distal bronchus with a diameter between 2-2.5 mm, and the maximum diameter D3 of the implantable artificial bronchus 100 may allow the implantable artificial bronchus 100 to support the bronchus wall 204 so that the bronchus wall 204 does not collapse and close the by air. In addition, the implantable artificial bronchus 100 can be inserted into the respiratory passage 202 located at distal portions via access through the central airway. The implant path can be initially defined with a malleable metal guide. A subsequent catheter passage can be performed to guide the implantable artificial bronchus 100 in a compressed state. However, the implantable compressed artificial bronchus 100 can be introduced directly by a guidewire.

[0046] Referring to Figure 10, the implantable artificial bronchus 100 may be flexible to allow the body 102 of the implantable artificial bronchus 100 to conform to the shape of a respiratory passage. For example, the implantable artificial bronchus 100 can be configured to weave back and forth and back as it enters the distal bronchioles. In one embodiment, the body 102 is configured to curve in a first radial direction along a first.

24/30 length of body 102 and a second radial direction opposite the first radial direction along a second length of body 102. Implantable artificial bronchus 100 can be configured to be flexible due to the intertwining of PEEK fiber 108. For example, the body 102 can be composed of a single braided fiber 108, which allows the crossing and sliding of several segments of the fiber 108 over one another during displacement of the implantable artificial bronchus 100. In one embodiment, the implantable artificial bronchus 100 does not include any element for coupling the various fiber segments 108, thus allowing them to move and slide over one another, increasing the flexibility of the implantable artificial bronchus 100. The flexibility of the implantable artificial bronchus 100 and body 102 allow the implantable artificial bronchus 100 to conform and remain stable within a respiratory passage without causing damage to surrounding tissues. Furthermore, the flexibility that a single implantable artificial bronchi 100 be used in a longer respiratory passage rather than multiple implantable artificial bronchi being used. In addition, the flexibility of the implantable artificial bronchus 100 allows it to reach respiratory bronchioles beyond level 15. The implantable artificial bronchus 100 can be configured to provide structure to the bronchus wall 204 while allowing the escape of air trapped within distal alveoli through of the central airway. The shape and flexibility of the implantable artificial bronchus 100 allows the implantable artificial bronchus 100 to come as close as possible to distal respiratory bronchioles, such as respiratory bronchioles beyond 15 and close to alveoli (levels >15).

[0047] In one embodiment, the side openings 110 of the body 102 allow air to enter the body 102 while the implantable artificial bronchus 100 is disposed within the respiratory passage. For example, as indicated by the arrows in Figure 10, air can enter the body 102 through the

25 / 30 lateral openings 110 from smaller lateral air passages. These smaller lateral air passages can be created as a result of collateral ventilation. This allows air to flow through the body 102 from the distal bronchioles while the implantable artificial bronchus 100 is implanted in the respiratory passage.

[0048] Referring to the Figures. 11A-B, a measuring catheter 400 can be used prior to insertion of the implantable artificial bronchus 100 into the respiratory passage. Measurement catheter 400 can be inserted into the channel bronchoscope to determine the depth of the desired target site within the respiratory passage. Measurement catheter 400 may be a steerable wire that can be inserted into the channel bronchoscope prior to delivery of the implantable artificial bronchus 100. For example, measurement catheter 400 may have a fixed diameter of approximately 2 mm. The diameter of the measuring catheter can be approximately 2 mm to prevent insertion beyond bronchioles less than 2 mm in diameter. The measuring catheter 400 with a fixed diameter of approximately 2 mm allows the measuring catheter 400 to measure the distance to which the bronchioles narrow down to approximately 2 mm. Measuring catheter 400 may include a distal end 406, a proximal end 404, and a handle 402. Distal end 406 and proximal end 404 may include markers 403. Markers 403 may be located at predefined intervals and viewed with a camera of the channel bronchoscope to determine the depth and space available to implant the implantable artificial bronchus 100 within the respiratory passage. In one embodiment, the 403 markers at the distal end 406 and the range in which they are located are identical to the 403 markers at the proximal end 404. This allows the user to determine depth without relying solely on the chamber, as the proximal end 404 can be located outside the channel bronchoscope. The 402 fist can be a

26 / 30 molded plastic handle and can be used to manipulate measurement catheter 400. In one embodiment, handle 402 is glued in place by filling a hole inside handle 402 with an adhesive.

[0049] Referring to the Figures. 12A-D, a delivery device 300 can be used to deliver the implantable artificial bronchus 100. Once depth is determined by the measuring catheter 400, the delivery device 300 can be used to deliver the implantable artificial bronchus 100 to the target site. Delivery device 300 may include delivery portion 301 and handle 310. Delivery portion 301 may include outer sheath 302, delivery wire 304, and stabilizer 308. Handle 310 may be coupled to a delivery portion 301 at the distal end 313 of the cuff 310. The implantable artificial bronchus 100 can be inserted into the delivery portion 301 and disposed within the delivery device 300 for delivery to a target site within the respiratory passage. For example, delivery device 300 can be inserted into a working channel of the bronchoscope. Delivery portion 301 can be inserted and advanced into the respiratory passage. Once the delivery portion 301 has reached the target site for delivery of the implantable artificial bronchus 100, an outer sheath 302 can be collected to expose the delivery wire 304 and the implantable artificial bronchus 100, allowing for delivery of the implantable artificial bronchus 100. at the target site. Delivery portion 301 can then be removed from the working channel of the bronchoscope.

The handle 310 may include the actuator 312, the stabilizer 308, the proximal end 311, the distal end 313, the anchor 316 and the outer surface 317. The actuator 312 may be disposed on the outer surface 317. In one embodiment, the actuator 312 can be disposed within the slot 319 on the outer surface 317. The actuator 312 can be actuated by a user's thumb to slide the actuator 312 from the proximal end 311 to the distal end 313. The actuator 312 can be

27/30 coupled to outer sheath 302 and may be configured to retract outer sheath 302 at handle 310 and expose delivery wire 304. For example, driver 312 may be coupled to a portion of outer sheath 302 disposed within handle 310 , thus resulting in the recoil of the outer sheath 302 on the handle 310 while the driver 312 is displaced towards a proximal end 311. The outer sheath 302 may pass through the stabilizer 308 to aid in the attachment of the outer sheath 302 on the handle 310. In one embodiment, outer sheath 302 is movable relative to stabilizer 308 and handle 310. Outer sheath 302 may include distal end 315, slit 307, and marker 318, and may be coupled to a distal end 313 of the handle. 310. Marker 318 can be used to help determine various locations of outer sheath 302 within the respiratory passage. Delivery wire 304 may be disposed within outer sheath 302 and be composed of a rigid material. Delivery wire 304 may extend from proximal end 311 of handle 310 to distal end 315 of outer sheath 302. Delivery wire 304 may be anchored at proximal end 311 of anchor 316 of handle 310. Anchor 316 may be configured to secure the delivery wire 304 such that the outer sheath 302 is movable relative to the delivery wire 304. The delivery wire 304 may include a locking cap 305, which can be disposed at the end of the delivery wire. delivery 304. The cap 305 may be disposed within the outer sheath 302 near the slit 307.

[0051] In one embodiment, the implantable artificial bronchus 100 is inserted into the distal end 315 of the outer sheath 302, near the slit 307, which is near the cap 305 of the delivery wire 304. The slit 307 may be located near the distal end 315 of the outer sheath 302. The implantable artificial bronchus 100 can be inserted into the distal end 315 by a suture threaded through a loop of the upper proximal opening 104. The ends of the suture can be passed through a funnel.

28 / 30 into the outer sheath 302 and exiting the slit 307. The implantable artificial bronchus 100 is inserted into the distal end 315 of the outer sheath 302 pulling the ends of the suture, which drags the implantable bronchus 100 through the funnel resulting in collapse of the implantable artificial bronchus 100. The continuously pulled suture ends draw the collapsed implantable artificial bronchus 100 to the distal end 315 of the outer sheath 302. The suture is pulled until the implantable artificial bronchus 100 reaches the slit 307, which is close to the cap 305 of the delivery thread 304. The suture can then be pulled through the slit 307 and removed from the implantable artificial bronchus 100. Once the implantable artificial bronchus 100 is inserted into the outer sheath 302, the implantable artificial bronchus 100 can expand.

For example, the body 102 of the implantable artificial bronchus 100 having a length L of approximately 50 mm may expand to a length L of approximately 80 mm within the outer sheath 302. By way of another example, the body 102 of the implantable artificial bronchus 100 with a length L of approximately 80 mm it can expand to have a length L of approximately 128 mm within the outer sheath 302. During initial insertion, the implantable artificial bronchus 100 can be shortened to its intended length.

Once the implantable artificial bronchus 100 has been inserted into the outer sheath 302 of the delivery portion 301, the outer sheath 302 can be inserted into a working channel of the bronchoscope.

Delivery portion 301 can be inserted into the respiratory passage and advanced to the target site.

Once the target site has been reached, the actuator 312 can be moved toward a proximal end 311 of the handle 310, thereby retracting the outer sheath 302 at the handle 310 and exposing the delivery wire 304, the cap 305 and the bronchus. Implantable Artificial Bronchus 100. Retraction of the outer sheath 302 does not cause the implantable artificial bronchus 100 to displace toward a handle 310 due to the force exerted by the delivery wire 304 and cap 305 on the artificial bronchus

29 / 30 implantable bronchus 100, preventing displacement of the implantable artificial bronchus 100. Once the outer sheath 302 has been withdrawn and exposed the implantable artificial bronchus 100, the implantable artificial bronchus 100 can expand to its original position within the respiratory passage. Delivery portion 301 of delivery device 300 can then be withdrawn from the respiratory passage through the working channel of the bronchoscope.

[0052] Experts in the subject will recognize that changes could be made to the exemplary modalities shown and described above without deviating from their broad inventive concepts. It is understood, therefore, that this invention is not limited to the exemplary embodiments shown and described, but is intended to encompass modifications within the spirit and scope of the present invention as defined by the claims. For example, specific features of the exemplary embodiments may or may not form part of the claimed invention, and various features of the described embodiments may be combined. The words “proximal”, “distal”, “superior” and “inferior” designate directions in the drawings to which reference is made. Unless specifically defined in the present tense, the terms "a", "an", "the" and "a" are not limited to one element, but rather, should be read to mean "at least one".

[0053] It should be understood that at least some of the figures and descriptions of the invention have been simplified to focus on elements that are relevant to a clear understanding of the invention, while eliminating, for clarity, other elements that those skilled in the art will recognize may also comprise a part of a portion of the invention. However, because they are well known in the art, and because such elements do not necessarily facilitate a better understanding of the invention, a description of such elements is not provided herein.

[0054] Furthermore, insofar as the methods of this

The invention is not based on the particular order of steps defined herein, the particular order of steps is not to be construed as a limitation on the claims.

Any claims directed to the methods of the present invention should not be limited to carrying out the steps thereof in the order written, and one skilled in the art will readily recognize that the steps may be varied and still remain within the spirit and scope of the present invention.

Claims (29)

1. Implantable artificial bronchus, characterized in that it comprises: a body with an upper proximal opening and a lower distal opening in fluid communication with the upper proximal opening, the body tapering at least partially along a length of the body towards the distal lower opening and having a plurality of lateral openings configured to allow the entry and exit of air from the implantable artificial bronchus through the body, wherein a body length is 4 times the size of a larger body diameter and, wherein a diameter of the upper proximal opening is greater than a diameter of the lower distal opening. 2. Implantable artificial bronchus according to claim 1, characterized in that the body includes a proximal portion, a first middle portion, a second middle portion and a distal portion, the proximal portion tapering towards a central geometric axis of the body. 3. Implantable artificial bronchus according to claim 2, characterized in that the first middle portion and the second middle portion are disposed between the proximal portion and the distal portion, the first middle portion being close to the proximal portion and the second portion mid portion being close to the distal portion, the first mid portion having a first taper and the second mid portion having a second taper, the second taper being greater than the first taper. 4. Implantable artificial bronchus according to claim 2, characterized in that a diameter of the first middle portion is greater than a diameter of the proximal portion, a diameter of the second middle portion and a diameter of the distal portion. 5. Implantable artificial bronchus according to claim 4, characterized in that the diameter of the distal portion is less than the diameter of the proximal portion, the diameter of the first middle portion and the diameter of the second middle portion. 6. Implantable artificial bronchus according to claim 4, characterized in that the diameter of the first middle portion is equal to or less than the largest diameter of the body. 7. Implantable artificial bronchus according to claim 4, characterized in that the diameter of the second middle portion constantly decreases along the length of the body from the first middle portion to the distal portion. 8. Implantable artificial bronchus according to claim 4, characterized in that the diameter of the distal portion is substantially equal near the second middle portion and close to the lower distal opening. 9. Implantable artificial bronchus according to claim 2, characterized in that the proximal portion widens from the upper proximal opening to the first middle portion. 10. Implantable artificial bronchus according to claim 1, characterized in that a maximum diameter of the body is greater than the diameter of the upper proximal opening. 11. Implantable artificial bronchus according to claim 1, characterized in that the body is a web comprised of the single fiber that forms a truss structure, the single fiber having ends woven together, close to a middle portion of the body. 12. Implantable artificial bronchus according to claim 1, characterized in that the diameter of the upper proximal opening is twice the diameter of the lower distal opening. 13. Implantable artificial bronchus according to claim 1, characterized in that the single fiber is coated with at least one of silicone or polymer. 14. Implantable artificial bronchus according to claim 1, characterized in that, in implanted state, the body is configured to curve in a first radial direction along a first length of the body and a second radial direction opposite to the first radial direction along a second body length. 15. The implantable artificial bronchus according to claim 1, characterized in that the plurality of lateral openings includes an angle ranging between approximately 130° near the upper proximal opening and 20° near the lower distal opening. 16. The implantable artificial bronchus according to claim 1, characterized in that it additionally comprises: at least one retrieval loop coupled to the body in the upper proximal opening. 17. The implantable artificial bronchus according to claim 16, characterized in that at least one retrieval loop extends from the upper proximal opening in a substantially parallel direction to a central geometric axis of the body. 18. The implantable artificial bronchus according to claim 1, characterized in that it additionally comprises: at least one radiopaque marker disposed in the body. 19. The implantable artificial bronchus according to claim 1, characterized in that the body has a maximum diameter of approximately 6 mm to approximately 12 mm. 20. Implantable artificial bronchus according to claim 1, characterized in that the body is comprised of PEEK. 21. Implantable artificial bronchus according to claim 1, characterized in that the body is comprised of NiTiNOL. 22. The implantable artificial bronchus according to claim 1, characterized in that the body includes the single fiber arranged in an alternating cross-weaving pattern. 23. The implantable artificial bronchus according to claim 1, characterized in that the implantable artificial bronchus does not include a valve or a nozzle attached to the body. 24. Implantable artificial bronchus, characterized in that it comprises: a body with an upper proximal opening and a lower distal opening in fluid communication with the upper proximal opening, the upper proximal opening tapering towards a central geometric axis of the body, and the body constantly tapering from a portion near the upper proximal opening toward a portion near the lower distal opening, and having a plurality of side openings configured to allow air in and out of the implantable artificial bronchus through the body, the body comprising: a proximal portion tapering towards a central geometric axis of the body; a first middle portion having a first middle taper; a second middle portion having a second middle taper greater than the first middle taper; and a distal portion having a constant distal diameter, wherein the first middle portion and the second middle portion are disposed between the proximal portion and the distal portion; wherein a diameter of the upper proximal opening is at least twice a diameter of the lower distal opening, and the diameter of the upper proximal opening is less than a maximum diameter of the body, the maximum diameter of the body being close to the upper proximal opening, and wherein, in an deployed state, the body is configured to curve in a first radial direction along a first length of the body and a second radial direction opposite the first radial direction along a second length of the body. 25. Method to promote pulmonary deflation, characterized in that the method comprises: inserting a catheter distally into a respiratory passage of a patient's lung, the catheter containing the implantable artificial bronchus, as defined in claim 1, compressed into the catheter; and withdrawing the catheter proximally to the implantable artificial bronchus, unsheathing the implantable artificial bronchus, causing the implantable artificial bronchus to naturally expand and remain in the respiratory passage, the implantable artificial bronchus configured to promote the widening of the respiratory passage. 26. Method according to claim 25, characterized in that the catheter is a guide catheter. 27. Method according to claim 25, characterized in that the implantable artificial bronchus extends to a passage of bronchioles. 28. A method for delivering the implantable artificial bronchus as defined in claim 1 into an air passage, characterized in that the method inserts the implantable artificial bronchus into a delivery device, the delivery device comprising: a handle with a proximal end, a distal end, an outer surface, and an actuator movable on the outer surface; a delivery portion including an outer sheath and a delivery wire, the outer sheath coupled to the handle actuator and extending outwardly from the distal end of the handle, the outer sheath having a distal end and at least one slit, wherein the implantable artificial bronchus is inserted into the delivery device through the distal end; and the delivery wire is coupled to a proximal end of the cuff and extending outwardly from the distal end of the cuff and into the outer sheath such that the delivery wire is disposed within the outer sheath, the delivery wire including a braking element, wherein the braking element is disposed close to the implantable artificial bronchus after insertion of the implantable artificial bronchus into the delivery device; inserting the delivery portion of the delivery device into a bronchoscope such that the outer sheath is disposed within a working channel of the bronchoscope; advancing the delivery portion through the bronchial passage through the bronchoscope; retract the external sheath, through the trigger, exposing the delivery wire and the implantable artificial bronchus, causing the implantable artificial bronchus to naturally expand and remain in the bronchial passage; and removing the delivery device from the bronchial passage through the working channel of the bronchoscope. 29. Method for delivering the implantable artificial bronchus according to claim 28, characterized in that the insertion of the implantable artificial bronchus into the delivery device comprises: threading a suture through at least one proximal loop of the implantable artificial bronchus; pulling the suture to cause the implantable artificial bronchus to collapse inserting the suture and implantable artificial bronchus through the distal end of the outer sheath; and removing the suture from the implantable artificial bronchus and the delivery device, through at least one slit, such that the implantable artificial bronchus remains in the delivery device.